ALKEM TELMISARTAN telmisartan 80 mg tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
29-04-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
telmisartan, Quantity: 80 mg
Available from:
Pharmacor Pty Ltd
INN (International Name):
Telmisartan
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: lactose monohydrate; crospovidone; povidone; sodium hydroxide; meglumine; colloidal anhydrous silica; magnesium stearate
Administration route:
Oral
Units in package:
28's (2 blisters of 14 tablets), 28's (4 blisters of 7 tablets), 10's (1 blister of 10 tablet)
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Telmisartan is indicated for:,Treatment of hypertension ,Prevention of cardiovascular morbidity and mortality in patients 55 years or older with,coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic,attack or high risk diabetes with evidence of end organ damage.
Product summary:
Visual Identification: White to off white oblong shaped biconvex, uncoated tablets debossed with TEL on one side and 80 on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-05-07
Patient Information leaflet
ALKEM TELMISARTAN
Ver 03
1
ALKEM TELMISARTAN TABLETS
Telmisartan
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about Alkem Telmisartan.
It
does
not
contain
all
available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and risks.
Your doctor has weighed the risks of
you
taking
this
medicine
against
the
benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
This leaflet was last updated on the date
at the end of this leaflet.
More recent
information may be available. The latest
Consumer
Medicine
Information
is
available from your pharmacist, doctor, or
from
www.medicines.org.au
and
may
contain important information about the
medicine and its use of which you should
be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again
WHAT ALKEM TELMISARTAN
IS USED FOR
Alkem Telmisartan is used to:
treat high blood pressure (also called
hypertension)
Prevent cardiovascular
complications, including death due to
cardiovascular causes, in patients
older than 55 years of age. with
coronary artery disease, peripheral
vascular disease, previous stroke,
previous transient ischaemic attack
(TIA) or high risk diabetes with
evidence of end organ damage.
TREATMENT OF HYPERTENSION
Alkem Telmisartan is used to lower high
blood pressure (hypertension).
Everyone
has
blood
pressure.
This
pressure helps your blood move around
your body. Your blood pressure may be
different at different times of the day,
depending on how busy or worried you
are.
You have hypertension (high blood
pressure) when your blood pressure stays
higher than normal, even when you are
calm or relaxed.
There
are
usually
no
signs
of
hypertension. The only way of knowing
that you have hypertension is to have
your
blood
pressure
checked
on
a
regular basis.
If high blood pressure is
not treated, it can lead to serious health
problems,
including
stroke,
heart
disease and kid
Read the complete document
Summary of Product characteristics
ALKEM TELMISARTAN
Ver 03
1
AUSTRALIAN PRODUCT INFORMATION – ALKEM TELMISARTAN (TELMISARTAN)
1.
NAME OF THE MEDICINE
Telmisartan
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Telmisartan is a specific angiotensin II receptor (type AT1)
antagonist. Telmisartan is an white or
slightly to yellowish crystalline powder. It is practically insoluble
in water, very slightly soluble in
ethanol, slightly soluble in methanol and soluble in a mixture of
chloroform and methanol (1:1).
ALKEM TELMISARTAN
is available in 2 strengths as tablets for oral administration
containing 40
mg and 80 mg of telmisartan.
ALKEM TELMISARTAN 40: Each tablet contains Telmisartan 40 mg.
ALKEM TELMISARTAN 80: Each tablet contains Telmisartan 80 mg.
Excipients with known effect: lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablets
ALKEM TELMISARTAN 40 mg
tablets:
White to off-white, oblong shaped biconvex, uncoated tablets debossed
with ‘TEL’ on one side and
‘40’ on other side.
ALKEM TELMISARTAN 80 mg
tablets:
White to off-white, oblong shaped biconvex, uncoated tablets debossed
with ‘TEL’ on one side and
‘80’ on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALKEM TELMISARTAN
is indicated for:
Treatment of hypertension
Prevention of cardiovascular morbidity and mortality in patients 55
years or older with
coronary artery disease, peripheral artery disease, previous stroke,
transient ischaemic
attack or high risk diabetes with evidence of end organ damage (see
SECTION 5.1
PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS).
ALKEM TELMISARTAN
Ver 03
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_TREATMENT OF HYPERTENSION:_
_Adults_: The recommended dose is 40 mg once daily. In cases where the
target blood pressure is
not achieved, telmisartan dose can be increased to 80 mg once daily.
Telmisartan may be used
in combination with thiazide-type diuretics such as
hydrochlorothiazide
which has
been
shown
to have an additive blood pressure
lowering
effect with telmi
Read the complete document
